United Therapeutics

Bavarian Nordic announced the sale of its Priority Review Voucher for $160 million, awarded following FDA approval of its chikungunya vaccine VIMKUNYA in February 2025.

Six pharmaceutical facilities received category awards for innovation, operations, and social impact at the 2025 ISPE Europe Annual Conference, marking the 20th anniversary of the prestigious FOYA program.

• AstraZeneca has inaugurated a new $300 million cell therapy manufacturing facility in Rockville, Maryland, designed to produce CAR-T cell therapies for cancer treatment and create over 150 specialized jobs. • The 84,000-square-foot facility is part of AstraZeneca's broader $3.5 billion investment in U.S. research and manufacturing, strengthening Montgomery County's position as a leading bio-life sciences hub. • The project received combined support of $600,000 from Montgomery County and Maryland state agencies, along with job creation tax credits and expedited permitting to accelerate the facility's completion.

A U.S. District Court has dismissed a legal dispute filed by United Therapeutics against Liquidia, marking a significant development in ongoing patent litigation between the two pharmaceutical companies.

U.S. District Court Judge Kelly dismissed United Therapeutics' cross-claim challenging Liquidia's NDA amendment for YUTREPIA, ruling that UTHR failed to establish standing.

Priority Review Vouchers (PRVs) have surged in value to $150-158 million in recent months, up from the typical $100 million, following Congress's failure to reauthorize the rare pediatric disease program.

The FDA has approved clinical trials for two companies, United Therapeutics and eGenesis, to transplant genetically modified pig kidneys into humans with kidney failure.

United Therapeutics received FDA clearance for its IND application to begin clinical trials for UKidney, a gene-edited pig kidney, marking a significant step in xenotransplantation.

• Two U.S. companies are planning to initiate clinical trials of xenotransplantation in 2025, utilizing pig kidneys and hearts to address the critical shortage of human organs. • Patients with end-stage organ failure, facing long waits and limited options, are actively pushing for and volunteering in xenotransplantation research. • Recent experiments involving gene-edited pig organs in humans, while having limited survival times, have provided valuable insights for refining xenotransplantation techniques. • Researchers are exploring various gene-editing strategies to enhance the compatibility of pig organs with the human immune system, with clinical trials expected to provide clarity on the optimal approach.

Towana Looney became the longest-living recipient of a pig kidney transplant, exceeding 60 days post-surgery, marking a significant milestone in xenotransplantation.